FDA Approves Vertex’s Non-OPIOid Pankiller, First New Kind of Pain Medicine In Decades

The food and drug administration on thuresday approved Vertex pharmaceuticals‘Non-opioid’ Painkiller Pill, a new alternative For pain relief that comes without the risk of addiction.

Vertex is now the first drugmaker in decades to gain us approval for a new type of pain medicine. It’s a milstone after a long history of Mostly Unsuccessful efforts to develop paintillers without Horific Epidemic of abuse and overdose in the US

Vertex’s Drug, Journavx, is specifically approved for the treatment of moderate-to-severe acute pain, which is usually caused by injury, surgery, incidence And likely eases with time. Around 80 Million Patients Are prescribed a medicine for their moderate-to-seedy pain every year in the US, according to Vertex.

Almost 10% of Patients with Acute Pain Who Are Treailed Initiah A statement.

“We have the opportunity to change the paradigm of acute Pain Management and Establish a new standard of care,” Dr. Reshma Kewalramani, Vertex Ceo, said in a statement,

Vertex Said Journavx will have a list price of $ 15.50 per 50-milligram pill. Wall Street Analysts Have Said That The Medication Block Blasts A Blockbuster Drug If it WINS Approval from regulators, Estimating its annual sales un expected $ 1 bill.

The experience of pain starts in a nerve ending, and the body detects the pressure and sends a signal to the spinal cord and then the brain. Vertex’s Treatment Works by Blocking Pain Signals at their Origin Before They Reach the Brain. That’s different from opioids, which act directly on the brain to block pain, triggering the brain’s rewards centers in a way that can feed addiction.

The approval underscores the “FDA’s Commitment to Approving Safe and Effective Alternatives to Opioids for Pain Management,” Said Dr. Jacqueline Corrigan-Curay, Acting Director of the FDA’s Center for Drug Evaluation and Research, in a release.

Vertex’s Pankiller was more effective than placebo at reduction the intensity of pain after 48 hours in two late-stage studies on more than 1,000 patients who had abdominoplasties, also know as “tummy tucks,” and rooughly another thoss in people in people who had bunion surgery. Theose two procedus are commonly used in studies of people with acute pain.

The Pankiller, however, failed to meet the secondary goal in both trials of Reducing Pain when Compared to a Combination of the opioid Drug Hydrocodone, Which Is Frequently Abused, And Acetaminop Ar Pain Medicals Such as Tylenol.

In Both Trials, Rates of Adverse Side Effects Were Lower in that who received vertex’s drug compared to people who Took a placebo. The most commonly reported adverse events among people who received Journavx was itching, muscle spasms and rash, among others, according to the fda.

In a separet phase three study, more than 83% of patients said in a survey that drug was good, very good or excellent at esing pain. Those people had undergone various surgical or non-surgical procedures.

The Bigger Opportunity for Vertex May Be To Win FDA Approval in Chronic Pain. That’s an area where the risk of addiction to prescription opioids can be great, according to the Centers for Disease Control and Prevention,

In 2023, The Company’s Painkiller Produced Positive Results in a Mid-STAGE TRIAL in Diabetes Patients Suffering from a Chronic Nerve Condition.